WEBINAR TODAY:
Listened in today and per usual, was impressed with Comella’s extensive knowledge, not only of Adipose stem cells but other types of procedures as well. Hundreds of people on the call today and she answers tons of great questions!
A few quick notes:
1.Comella confirmed that they have acquired Venable (Law-firm giant with extensive ties and history with the FDA, specifically getting new products to market and guideline creation) to represent them and they have for months been working side by side with the FDA to help frame how stem cells will be looked at by law moving forward.
2. Comella stated that USRM’s OFFICIAL stance in reference to the FDA is that they are conducting business as usual and per they’re Law firm, the FDA can NOT control your own cells. It would be a constitutional violation for them to do so.
She went on to also say that Jeff Sessions signed a document that says that guideline documents can not be held as LAW. Therefore the recent FDA guideline document that speaks of minimal manipulation is just that, a GUIDELINE DOCUMENT. The FDA would have to go through Congress to get this Guideline document to actual pass as law which is the only way they could enforce it effectively. This more than likely has A LOT to do with the three year grace period of enforcement that was given by the FDA.
3. She was VERY excited when asked about Myocell and Myocell SDF-1 and they’re effectiveness. Stated that they are working with they’re law firm (venable) to work with the FDA On getting specifics on exactly where they’re Phase 2/3 trials land them. She did say however that CURRENTLY even under RTT in Texas they can’t just yet administer Myocell treatments, they can however deliver adipose stem cells to the heart for recently-heart attacked patients. SHE ALSO STATED THAT THEY DO HAVE FACILITIES OVER SEAS THAT ARE ADMINISTERING MYOCELL TREATMENTS.
4. She stated that they’ll be doing a webinar with Ben Greenfield soon to speak about his recent procedure!
Did I miss anything?
